Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code Reduced- Montage Standard Electroencephalograph (OMC) (2) Standard Polysomnograph With Electroencephalograph (OLV) (2) Automatic Event Detection Software For Polysomnograph With Electroencephalograph (OLZ) (1) Ventilatory Effort Recorder (MNR) (1)